| CTRI Number |
CTRI/2026/01/101437 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the reasons why some patients find it difficult or uncomfortable to use spectacles |
|
Scientific Title of Study
|
Understanding spectacle intolerance in patients visiting a tertiary eye hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of optometry, second floor, sankara college of optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Department of optometry, second floor, sankara college of optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of optometry, second floor, sankara college of optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Department of optometry, second floor, sankara college of optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Kamath |
| Designation |
Head of Department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of optometry, second floor, sankara college of optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9820541584 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Department of optometry, second floor, sankara college of optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore India 560037
560037 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namratha |
Sankara Eye Hospital |
Department of optometry, second floor, sankara college of optometry, Sankara Eye Hospital Varthur main road Kundalahalli gate, Bangalore, 560037
Bangalore
KARNATAKA |
9820541584
vandu2388@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Refractive error 123 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Have received spectacles from
hospital and intolerance with
spectacles
Single vision glasses
Bifocal glasses
Multifocal PAL |
|
| ExclusionCriteria |
| Details |
Ocular pathological conditions
Dense cataract retinal and
macular conditions glaucoma
Prism
Amblyopia
Strabismus
Myopia defocus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the causes of spectacle intolerance among patients visiting a tertiary eye hospital, using the IND-VF-33 questionnaire. |
4 weeks To identify the causes of spectacle intolerance among patients visiting a tertiary eye hospital, using the IND-VF-33 questionnaire. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Develop & validate a standardized protocol for troubleshooting spectacle intolerance in a tertiary eye hospital setting. |
1 time |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To identify the causes of spectacle intolerance among patients visiting tertiary eye hospital using the IND-VF-33 questionnaire and a standardized troubleshooting protocol. It also seeks to develop and validate the protocol and analyze factors influencing intolerance to improve patient satisfaction and clinical care. |